23 sep
|
Syneos Health
|
Santander
23 sep
Syneos Health
Santander
Overview
As a Senior Clinical Trial Manager, you will oversee site management, monitoring, and data integrity for oncology trials from a home base in Spain. You'll coordinate a cross-functional clinical team to achieve study milestones, manage risks, and ensure protocol and regulatory compliance. You'll act as a key liaison with investigators, sites, and sponsors, driving quality and delivery while supporting inspections readiness.
This role offers impact across the drug development continuum, with opportunities to shape trial delivery and processes in a fast-paced, inclusive environment.
Compensaciones / Ventajas career development inclusive culture total rewards program technical and therapeutic area training
Responsabilidades
Oversee site management, clinical/central monitoring deliverables with emphasis on patient safety and data integrity
Manage site interactions from activation to closeout, including recruitment and investigator payments
Identify and mitigate risks using data, escalating issues to project management as needed
Coordinate and review study scope, budget, and protocol content to align with contractual obligations
Lead and participate in key meetings (e.g., Kick Off) and provide status updates on deliverables and risks
Develop and maintain study tools/templates (e.g., Clinical Monitoring Plan) and ensure CTMS and dashboards are usable
Provide initial and ongoing training to study teams on protocols, CRFs, SOPs, data plans,
and timelines
Oversee resourcing allocations for CRAs and Central Monitors and monitor team conduct and delivery quality
Review monitoring documentation and ensure timely updates in CTMS and other systems
Interact with client and other functions to resolve obstacles and ensure compliance with protocol and regulatory requirements
Support inspections readiness and implement corrective action plans as needed
Mentor and coach CTMs on clinical delivery, risk assessment, and action implementation
May coordinate activities across a portfolio of projects or larger, more complex trials
Requisitos principales Bachelor's degree or RN in a related field or equivalent
Proven vendor management experience
Global study management experience
Experience in Oncology clinical trials
Strong experience reviewing and overseeing study plans and documentation
Ability to lead and align teams to milestones
Experience in international environments
Expertise in site management and monitoring (clinical or central)
Knowledge of risk-based monitoring (preferred)
Budget management and understanding of clinical trial financial principles
Knowledge of GCP/ICH and regulatory requirements
Strong computer and data skills; conflict resolution and problem-solving abilities
Willingness to travel ~20%
leadership communication problem solving
CTMS
EDC eDiary
📌 Global Sr CTM - Home Based in SPAIN. FSP. Oncology experience is required.. (Santander)
🏢 Syneos Health
📍 Santander